Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT01007656
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult, aged between 20 to 40 years old
* Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest X-ray and electrocardiogram
* The normal range of the body mass index should between 18.5 and 24.9; body mass equals \[weight(Kg)\]/\[height(m)\]2
* Normal laboratory determinations results (within normal range or considered not clinically significant by the investigator) including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, γ-GT, alkaline phosphatase, total bilirubin, D-Bil, BUN, TP, GLO, HBsAg and Anti-HCV.
* Normal hematology results (within normal range or considered not clinically significant by the investigator) including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count.
* Normal urinalysis results (within normal range or considered not clinically significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts and bacteria.
* Female subject who is using adequate contraception since last menstruation and no plan for conception during the study
* Female subject who is non-lactating
* Female subject who has negative pregnancy test (urine) within 14 days prior to the study
* Informed consent form signed
Exclusion Criteria:
* A recent history of drug or alcohol abuse
* Medical history of allergic asthma or sensitivity to analogous product
* A clinically significant illness within the past 4 weeks.
* Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoetic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.
* Ongoing peptic ulcer and constipation.
* Planed vaccination during the time course of the study.
* Participation of any clinical investigation during the last 60 days.
* Regular use of any medication during the last 4 weeks.
* Single use of any medication during the last one week.
* Blood donation of more than 500 mL within the past 12 weeks.
* Individuals are judged by the investigators or co-investigator to be undesirable as subjects.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT01007656
Study Brief:
Protocol Section:
NCT01007656